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Completed

NCT Number: NCT05796128

NIPPV vs.nCPAP During LISA Procedure

The goal of this randomized controlled study is to compare the efficacy of using NIPPV versus NCPAP during the LISA procedure in very preterm infants.

The main question it aims to answer is:

• Does NIPPV during the LISA procedure decrease the need for a second dose of surfactant or the need of mechanical ventilation during the first 72 hours of life in comparison with NCPAP? Infants with gestational age between 25+0 and 31+6 weeks of gestation with RDS who do not require VM and treated with NCPAP and FiO2 >0.30 within the first 6 hours of life who received the first dose of caffeine will be eligible for enrollment in the study Participants will be randomized to receive surfactant with conventional LISA procedure, i.e. performed during NCPAP, or with LISA procedure performed during NIPPV.

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Key information

Conditions

Respiratory Distress Syndrome, Newborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Urogenital Diseases

Age range

0 hour–72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Careggi University Hospital, Division of Neonatology

Florence, 50141, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • -Infants with gestational age between 25+0 and 31+6 gestational weeks,
  • -RDS which does not require MV
  • -Treatment with NCPAP and FiO2 >0.30 within the first 6 hours of life,
  • -First dose of caffeine administered

Exclusion criteria

  • -absence of informed consent,
  • -major congenital malformations,
  • -hydrops fetalis,
  • -chromosomal diseases,
  • -previous treatment with surfactant,
  • -cardiorespiratory instability requiring treatment with vasoactive drugs,
  • -pneumothorax,
  • -death within 72 hours of life.

Treatment and study plan

Nasal Intermittent Positive Pressure Ventilation (NIPPV)

Procedure

In this group, infants will receive NIPPV during LISA procedure.

Nasal continuous positive airway pressure (NCPAP)

Procedure

In this group, infants will receive NCPAP during LISA procedure.

Primary outcomes

  1. Surfactant or mechanical ventilation

    Time frame: The need for a second dose of surfactant or mechanical ventilation will be evaluated within the first 72 hour of life

    Need for a second dose of surfactant or mechanical ventilation

Secondary outcomes

  1. Noninvasive ventilation

    Time frame: Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks

    Duration of noninvasive ventilation

  2. Mechanical ventilation

    Time frame: Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks

    Duration ofmechanical ventilation

  3. Bronchopulmonary dysplasia

    Time frame: Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks

    Frequency of mild, moderate, and severe bronchopulmonary dysplasia

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Registry information

Official study title

Nasal Intermittent Positive Pressure Ventilation Versus Nasal Continuous Positive Airway Pressure Durante la Somministrazione Del Surfattante Con Tecnica LISA

Acronym: NIPAL

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Apr 3, 2023
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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